Quality Assurance and R&D Manager - QM

Summary:

The Quality Assurance Manager ensures all Research and Development (R&D) design artifacts and processes satisfy applicable requirements established by the Food and Drug Administration and the client company. This individual is responsible for the development and implementation of an R&D internal audit control process, to include: annual reviews, continuous improvement, and metrics. Other responsibilities include: performing risk analysis, oversight of design transfer, analysis of design input and design output to approved designs, and corporate-level planning.

Responsibilities

• Recommend and maintain Design Control programs and systems to support corporate quality policy, regulatory requirements, and quality objectives.
• Ensure R&D compliance with applicable regulations such as the FDA QSR, EU MDD, Canadian CMDR, and Australian TGA.
• Process complaints assigned to R&D for investigation per quality system regulations.  Ensure timely and effective failure investigations and corrective action per worldwide requirements.
• Conduct conformity assessment audits of R&D policies, procedures and quality systems to identify non-conformities and ensure prompt and effective corrective actions are accomplished.
• Work with Corporate Regulatory and Quality Assurance to obtain necessary pre-market clearances and/or approvals from domestic and international regulatory agencies, competent authorities and notified bodies.
• Work with Engineering to proactively and reactively develop and implement practical, timely, and effective business solutions to quality and regulatory issues.
• Gather and present R&D quality performance statistics on a regular and timely basis
• Investigate, document, report and track the root cause of R&D related quality problems
• Establish appropriate corrective actions and improvements for R&D
• Plan, perform, document, report and track internal R&D audits and all corrective actions
• Track status of complaints assigned to R&D and generate status reports for senior management
• Manage R&D implementation of the Quality Management System; to include adherence to the Quality Manual and supporting procedures
• Create and maintain R&D specific Quality Management System documents and records, including summaries and management reports
• Advise senior management on quality-related continuous process improvement opportunities for R&D
• Assist R&D with the development and revision of R&D procedures and work instructions
• Establish and manage all internal R&D audits and functions as the R&D point of contact for all external audits
• Function as an independent auditor for all design control activities
• Establish metrics for R&D quality initiatives and tracks R&D corrective and preventative actions
• Other responsibilities as may be assigned.

Required

• Baccalaureate Degree in Engineering or Science
• 10+ years of experience with medical device regulatory and quality systems
• 10+ years of experience with medical device design controls
• Creative problem solving, flexibility, and good negotiation skills
• Proven ability to communicate effectively with staff at all levels of the organization

Desirable

• Technical writing skills
• Ability to speak in front of large audiences
• Proven ability to drive practical results to a timely conclusion